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RVP-001 for Healthy Subjects

Phase 1
Waitlist Available
Led By Jeffrey Levy, MD
Research Sponsored by Reveal Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy subjects aged 18 to 55 years inclusive
Have a body mass index between 18 and 32 kg/m^2 (inclusive); weigh at least 55 kg.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
Awards & highlights

Study Summary

This trial is testing a new drug, RVP-001, to see if it is safe and tolerated by healthy adults, and to understand how it is metabolized and eliminated by the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Suitable veins for phlebotomy, cannulation, or repeated venipuncture.
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You are a male or female who is at least 18 years of age.
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You are informed of the study and are able to give informed consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK Parameter Cl
PK Parameter Tmax
PK Parameter Vd
+2 more
Secondary outcome measures
% RVP-001 Dose Excreted

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT05413668
17%
Back Pain
17%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
RVP-001: 4 mg Mn/kg
RVP-001: 7 mg Mn/kg
Placebo Group
RVP-001: 2 mg Mn/kg
RVP-001: 12 mg Mn/kg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RVP-001 groupExperimental Treatment1 Intervention
4 Cohorts of 6 subjects each will receive RVP-001 at doses of 2, 4, 7 and 12 mg Mn/kg.
Group II: Placebo groupPlacebo Group1 Intervention
4 Cohorts of 2 subjects each will receive placebo (saline).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RVP-001
2022
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Reveal Pharmaceuticals Inc.Lead Sponsor
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,614 Total Patients Enrolled
Quotient SciencesIndustry Sponsor
47 Previous Clinical Trials
1,386 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New Mexico
Florida
How old are they?
18 - 65
What site did they apply to?
Quotient Sciences
What portion of applicants met pre-screening criteria?
Met criteria
~11 spots leftby Mar 2025